Informed Consent
Item
1. ability to understand and the willingness to sign a written informed consent.
boolean
C0021430 (UMLS CUI [1])
Squamous cell carcinoma of the head and neck TNM clinical staging
Item
2. stage iii or iv epidermoid cancer of the head and neck.
boolean
C1168401 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Curative treatment Head and Neck Carcinoma
Item
3. within two weeks of starting or from having started, curative intent therapy for head and neck cancer.
boolean
C1273390 (UMLS CUI [1,1])
C3887461 (UMLS CUI [1,2])
Age
Item
4. age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
Liver function
Item
5. adequate liver function as defined by:
boolean
C0232741 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
alt < 5 x institutional upper limit of normal (uln)
boolean
C0201836 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
ast < 5 x institutional uln
boolean
C0201899 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin < 5 x institutional uln
boolean
C1278039 (UMLS CUI [1])
Racial group All | Ethnic group All
Item
6. both men and women of all races and ethnic groups are eligible for this trial.
boolean
C0034510 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C0015031 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
Antidepressive Agents Dose unchanged
Item
7. use of antidepressants is permitted if dose has been the same for at least 12 weeks prior to study entry.
boolean
C0003289 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods | Gender Partner Childbearing Potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
8. women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0700589 (UMLS CUI [2,4])
C2985296 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
Study Subject Participation Status | Investigational New Drugs
Item
1. receiving another investigational agent on a clinical trial that prohibits participation in other studies of investigational agents.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Major Depressive Disorder | Schizophrenia | Bipolar Disorder | Delirium | Psychotic Disorders
Item
2. meets mini international neuropsychiatric interview (mini) criteria for major depression, schizophrenia, bipolar illness, delirium or psychosis.
boolean
C1269683 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
C0011206 (UMLS CUI [4])
C0033975 (UMLS CUI [5])
Moderate depression QIDS-SR | Severe depression QIDS-SR
Item
3. has moderate to severe depression according to quick inventory of depressive symptomatology-self rated 16 (qids-sr-16) scores of ≥ 11.
boolean
C0588007 (UMLS CUI [1,1])
C4331197 (UMLS CUI [1,2])
C0588008 (UMLS CUI [2,1])
C4331197 (UMLS CUI [2,2])
Suicide risk assessment Score
Item
4. has suicidal risk assessment (sra) scores ≥ 6.
boolean
C0558000 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Monoamine Oxidase Inhibitors
Item
5. use of monoamine oxidase inhibitors within 14 days of study entry.
boolean
C0026457 (UMLS CUI [1])
Malignant melanoma of head and neck | Malignant lymphoma of head, face, and neck
Item
6. diagnosed with melanoma or lymphoma cancer of the head and neck.
boolean
C0587060 (UMLS CUI [1])
C0432556 (UMLS CUI [2])
Allergic Reaction Ketamine | Ketamine allergy
Item
7. history of allergic reactions or hypersensitivity to ketamine.
boolean
C1527304 (UMLS CUI [1,1])
C0022614 (UMLS CUI [1,2])
C0570631 (UMLS CUI [2])
Heart failure Severe New York Heart Association Classification | Heart Disease Uncontrolled | Heart Disease Unstable | Coronary Artery Disease Uncontrolled | Coronary Artery Disease Unstable
Item
8. severe cardiac insufficiency (nyha iii or iv), with uncontrolled and/or unstable cardiac or coronary artery disease.
boolean
C0018801 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0018799 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C1956346 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C1956346 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
Tachyarrhythmia | Angina Pectoris Severe | Myocardial Ischemia
Item
9. history of significant tachyarrhythmia, severe angina, or myocardial ischemia
boolean
C0080203 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0151744 (UMLS CUI [3])
Poor hypertension control | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents | Antihypertensive Agents Absent
Item
10. poorly controlled hypertension (systolic blood pressure > 180 mmhg or diastolic blood pressure > 1000 mmhg), with or without antihypertensives.
boolean
C0421190 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0003364 (UMLS CUI [4])
C0003364 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
11. pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])